Artex Risk Solutions

QA Engineer

• Responsible for Quality Assurance functions and design development activities of Class I and II medical devices in compliance with FDA, ISO, CMDR Quality Systems and Design Control requirements.
• Lead design assurance efforts within product design and development for new product introduction projects with emphasis on software, electrical, and/or mechanical device characteristics.
• For electrical/active device projects, lead compliance for electrical safety, environmental, and emissions per national and international regulations.
• Ensure appropriateness of documented design requirements and outputs and maintain traceability throughout product development lifecycle.
• Provide leadership implementing regulations/standards and act as resource to other disciplines from idealization through product retirement.
• Supervise, assign, and coordinate work of others within the design assurance team to support department and project goals.
• Lead lessons learned initiatives to improve design processes and the quality management system.
• Lead product risk assessment activities using ISO14971, FMEAs, FTA, and Hazard Assessment.
• Provide guidance on usability/human factors engineering principles (IEC 62366) and FDA guidance for compliance.
• Facilitate planning, execution, and review of verification/validation activities including assessment of inputs to the v&v process.
• Lead design assurance aspects of Design to Manufacture Transfer, including inspection methods, drawing reviews, KPIs, and manufacturing training.
• Ensure required outputs of design control are met, maintain Design History File (DHF), and support transition to sustaining engineering.
• Support design-related corrective and preventative activities and establish/maintain Risk Management File(s).

Senior Engineer I – QA Design

Full-stack Engineer

• Arthrex is a global medical device company and leader in new product development and medical education in orthopedics
• Software Engineers design, develop, test, and maintain high-quality software to meet business and customer needs
• Develop features and capabilities for end users and configure/customize vendor-provided packaged software
• Sr. SAP Integration developer and technical thought leader: lead projects using SAP PO and Cloud integration tools throughout complete lifecycle
• Architect and build application integration solutions and understand integration patterns and best practices for creating integration ABAP objects
• Analyze ABAP code objects, complex business processes, and create technical requirements and specifications for SAP work streams
• Configure SAP Web Services and ALE distribution models and lead offshore development teams
• Prepare technical documentation, participate in production support, and adhere to Quality System Procedure and Change Control
• Lead design for full stack development, mentor lower-level engineers, implement CI/CD improvements, and monitor applications for availability and performance improvements

Senior Software Developer, SAP PO

Manager

MAIN OBJECTIVE: Works with Regional Director to: Ensure maximized revenue growth of assigned company products and services through direct and indirect management of an independent sales force in a defined geographic product area. Establish proper and effective communications with appropriate staff across the company to ensure the proper level of sensitivity to the needs of sales. ESSENTIAL DUTIES AND RESPONSIBILITIES: Works within an assigned geographic sales and product area to maximize sales revenues and meet corporate objectives: Carries out specific plans developed by the Regional Director and company to ensure revenue growth in company’s products. Manages assigned account activities. Communicates regular field activity to President, SVP of Sales, Regional Director, and other internal management. Completes LMS self-education requirements. Develops independent sales team (agency): Monitors and assists in the activities of agency (product training, coaching representatives, TC program, motivates, recommends representative additions and termination as necessary, etc.). Educates sales team in terms of sales tactics. Recommends sales programs and training ideas to Regional Director and SVP Sales to address the following issues: New and existing account sales growth. Sales of new and existing products and multi-product sales. Competitive strategies and targeted sales campaigns. Proper use and level of sales support. Account and Third-party contracts. Performs sales activities on accounts and negotiates product pricing discounts pre-approved by the Regional Director and SVP of Sales. This job requires that a person must travel 3+ days out of the week and occasionally work on weekends.

Regional Manager, Sports Medicine

• Oversee Imaging and Resection product sales performance, training, and activities within region
• Implement sales strategy for agency Imaging and Resection business
• Follow up with agencies frequently to ensure strategy is being executed
• When needed identify weaknesses and offer evidence-based solutions
• Ensure agencies are properly structured to maximize growth and competency of product line
• Assisting with recruitment of experienced capital managers and deploying Arthrex training programs
• Collaborate regularly with Arthrex Regional Management team to achieve organizational objectives across product portfolio
• Launch Imaging and Resection new products within region
• Present Synergy imaging and resection products as well as bundled strategy at high level meetings
• Communicating with high level admin and IT regarding imaging product HIPAA compliance, integration, and networking capabilities
• Govern Imaging & Resection product pricing structure and qualifying discounts as they relate to product bundling
• Assisting representatives with trialing and closing activities at key accounts and reporting back to agencies on representative sales readiness as it relates to Imaging and Resection
• Creatively building custom solutions to maximize opportunity and business impact
• Communicating agency focus and structure as it relates to imaging and resection to North American Director of Sales I&R, Regional Director, Senior Director of Sales East, and VP Sales
• Communicating product performance to product management and North American Director of Sales while recommending product line enhancements
• Collecting key competitive information and ensuring that knowledge drives both sales effectiveness and product development direction
• Coaching, teaching, and when necessary, directing agency personnel via conference calls, virtual meetings, and in person visits on products/sales strategy/competitive info
• Travel up to 75% of the time

Regional Manager- Imaging & Resection- Central Region

• Oversees Spine product sales performance, training, and activities with sales force, surgeons, and accounts in region
• Implements sales strategy for agency Spine business; follows up with agencies; identifies weaknesses; offers evidence-based solutions
• Ensures agencies are structured to maximize growth; assists with recruitment; deploys Arthrex training programs
• Organizes and leads agency Spine training; launches Spine new products within region
• Presents Spine products and bundled strategy at high-level meetings
• Governs Imaging & Resection product pricing and discounts
• Assists representatives with trialing and closing; reports to agencies on readiness
• Builds custom solutions to maximize opportunity and business impact
• Communicates agency focus to North American leadership; shares product performance with management; recommends enhancements
• Collects competitive information; uses insights to drive sales effectiveness and product direction
• Coaches and directs agency personnel via calls, virtual meetings, and in-person visits
• Travel up to 75%

Regional Manager-Spine-Southeast & South Atlantic Regions

Business Development Rep

• Set business development strategy and asset deployment for agency Cardiothoracic business. Follow up with agencies frequently to ensure strategy is being executed. When needed identify weaknesses and offer evidence-based solutions.
• Serve as a resource to agencies to maximize growth and competency of product line.
• Launch Cardiothoracic new products within region. Re-launch when necessary.
• Govern Cardiothoracic product pricing structure and qualifying discounts as they relate to volume and commitment levels. Heavy intervention is required here due to the strategic nature of the Cardiothoracic product line. Working with local, regional and national buying groups is essential.
• Assisting representatives with evaluation and closing activities with key customers and collaborating with agencies on representative sales readiness as it relates to Cardiothoracic.
• Training representatives on Cardiothoracic products and sales cycle as needed.
• Communicating agency focus and structure as it relates to Cardiothoracic to Director of Global Cardiothoracic Business Development, Senior RM and SVP Sales.
• Communicating product attributes and shortcomings to product managers and recommending product line enhancements.
• Collecting key competitive information and ensuring that knowledge drives both sales effectiveness and product development direction.
• Coaching, teaching, and when necessary, directing Cardiothoracic team via conference calls and in person visits on products/sales strategy/competitive info.
• Engage current and identify new Key Opinion Leaders for Local, Regional, and National peer to peer interactions.
• Lead or assist on 2-3 projects every 6 months.
• Up to 75% travel.

Job title: Business Development Manager - Cardiothoracic- West

Medical writer

• Manage regulatory medical writing for international markets; write, edit, and review CEPs, CERs, PMCF plans, SSCPs, PMS plans, PMSRs, and PSURs in accordance with global regulatory requirements to support Arthrex’s regulatory compliance and global market sales.
• Collaborate with cross-functional teams (Regulatory, Clinical, Quality, Marketing) to ensure submission-ready clinical documentation; liaise with Project Manager and other cross-functional teams as applicable to provide input and gather required information.
• Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation; review or edit clinical regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures.
• Maintain periodic updates, perform gap analysis, and revise existing documents as necessary; participate in audits; may develop or conduct employee training.